Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions

Atherosclerosis Clinical Trial

— DCAT  

Official title:

Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00640744
• Other study ID #: H-18077
• Secondary ID: HL 063090
• Status: Recruiting
• Phase: Phase 4
• First received: January 2, 2008
• Last updated: December 2, 2010
• Start date: February 2006
• Est. completion date: February 2010

Study information

• Verified date: December 2010
• Source: Baylor College of Medicine
• Contact: William Insull, M.D.
• Phone: 713-798-4128
• Email: winsull[@]bcm.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.

Description:

Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Men or women

• >18 yrs old

• Expected to have an endarterectomy on each carotid artery

• No contraindications for atorvastatin

• Stable cardiovascular health

• Lipid lowering treatment less than 6 mo duration

• Diabetic included if diabetes is controlled

• Patient is not claustrophobic

• Patient has evaluable carotid plaques.

Exclusion Criteria:

• Patient has had previous carotid endarterectomy,stenting, or other procedure

• Unstable cardiovascular status

• Hypersensitivity to statin therapy

• Neck anatomy preventing acquiring bilateral evaluable plaques

• Weight over 285 lbs.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Atorvastatin
Atorvastatin 80 mg tablet/day for 3 months

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Choudhary S, Higgins CL, Chen IY, Reardon M, Lawrie G, Vick GW 3rd, Karmonik C, Via DP, Morrisett JD. Quantitation and localization of matrix metalloproteinases and their inhibitors in human carotid endarterectomy tissues. Arterioscler Thromb Vasc Biol. 2006 Oct;26(10):2351-8. Epub 2006 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in carotid plaque composition as assessed by MRI and histology		3 months	No
Secondary	Changes content of cells, proteins and genes in carotid plaque		3 months	No
Secondary	Changes in content of selected proteins and their encoding genes in carotid plaques		3 months	No

External Links

•   Atherosclerosis and Vascular Biology Research Training Program